Proximal Humeral Comminuted Fractures in the Elderly - PERCELE Trial

NCT00999193 | Terminated

• 1 other identifier: HUS-428/13/03/02/08
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Fractures of the proximal humerus are common in elderly patients. The optimal treatment of comminuted, displaced fractures is subject to controversy, and the results of operative treatment have not been shown to be superior to conservative treatment. The aim of the study is to compare locking plate osteosynthesis versus treatment with fracture hemiarthroplasty versus conservative treatment in a randomised, controlled protocol. The results of treatment are measured at 6 weeks, 3 months, 6 months, 12 months and 24 months. Main outcome measures are Pain at rest and activity (NRSs) and functional assessment of the shoulder with Constant Score. Secondary outcome measures are Simple Shoulder test (SST), Disabilities of the Arm, Shoulder and Hand (DASH), quality of life assessment (15D), subjective patient satisfaction and costs. The study also has a cohort follow-up of the patiens who decline randomisation. The recruitment target was 90 patients, but the study recruitment was stopped due to slow recruitment (too few patients presenting with eligibile injury to the hospital) at 60 patients in November 2019.

Conditions

Humeral Fracture

Keywords

Shoulder; Fracture; Locking Plate; Hemiarthroplasty; Conservative; Comminuted Proximal Humerus Fracture

Outcome Measures

Primary Outcomes (3)

• Pain at rest Numeric Rating Scale 0-10 (NRS)

  6 weeks, 3 mo, 6 mo, 1 year, 2 years

• Pain in active motion NRS

  6 weeks, 3 mo, 6 mo, 1 year, 2 years

• Constant Score

  3 mo, 6 mo, 1 year, 2 years

Secondary Outcomes (5)

• Simple Shoulder Test (SST)

  3 mo, 6 mo, 1 year, 2 years

• Disabilities of the Arm, Shoulder and Hand (DASH)

  3 mo, 6 mo, 1 year, 2 years

• Quality of life assessed with 15D

  6 weeks, 3 mo, 6 mo, 1 year, 2 years

• Subjective satisfaction

  6 weeks, 3 mo, 6 mo, 1 year, 2 years

• Complications

  6 weeks, 3 mo, 6 mo, 1 year, 2 years

Study Arms (3)

Conservative Treatment

ACTIVE COMPARATOR

Other: Conservative treatment

ORIF w. locking plate, no luxation

EXPERIMENTAL

Procedure: locking plate, ORIF

Hemiarthroplasty, no luxation

EXPERIMENTAL

Procedure: Hemiarthroplasty

Interventions

locking plate, ORIF PROCEDURE

Open reduction of the fracture (and GH joint), internal fixation with a locking plate. Tuberculum fragments are sutured to the plate with thick non-absorbable suture.

ORIF w. locking plate, no luxation

Hemiarthroplasty PROCEDURE

Replacement of the humeral articular head with hemiprosthesis. Tubercles are sutured to the prosthesis with thick nonabsorbable sutures.

Hemiarthroplasty, no luxation

Conservative treatment OTHER

Immobilisation in a supporting brace for 3 weeks, then increasingly active rehabilitation program supported by a physiotherapist until 12 weeks of the injury.

Conservative Treatment

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years and older
• Acute trauma: 1. randomisation (op vs cons) within 7 days of injury.
• or 4-part fracture with \>5mm dislocation of the anatomic neck.
• AO classification C1-2 for non-luxation fractures
• AO classification C3 for luxation fractures

You may not qualify if:

• Head Splitting fracture
• Open fracture
• Additional fractures in the shoulder region
• Other injuries requiring surgical treatment
• Clinically significant injury of the brachial plexus or vasculature
• Pathological fracture associated with cancer
• History of a fracture of the clavicle, scapula or humerus, or history of a very significant disease or trauma of the shoulder region (hemiparesis, tumour, osteomyelitis, grave arthrosis etc)
• Rheumatoid Arthritis in the shoulder requiring active treatment
• Reduced co-operation or incapability for independent living (dementia, mental illness, drug- or alcohol abuse etc)
• unwillingness to accept some of the treatment options.

Sponsors & Collaborators

• University of Helsinki: lead
• Helsinki University Central Hospital: collaborator
• Finnish Institute for Health and Welfare: collaborator

Study Sites (1)

Töölö Hospital Trauma Center, Helsinki University Central Hospital,

Helsinki, Finland

Location

Related Publications (1)

• Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.

  PMID: 35727196 DERIVED

MeSH Terms

Conditions

Humeral Fractures; Fractures, Bone

Interventions

Hemiarthroplasty; Conservative Treatment

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation; Therapeutics

Study Officials

• Tuomas Lähdeoja, MD

  University of Helsinki

  PRINCIPAL INVESTIGATOR

• Mika Paavola, MD, PhD

  University of Helsinki

  STUDY DIRECTOR

• Jarkko Pajarinen, MD, PhD

  University of Helsinki

  STUDY DIRECTOR

• Seppo Koskinen, MD, PhD

  University of Helsinki

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 20, 2009
• First Posted: October 21, 2009
• Study Start: November 1, 2010
• Primary Completion: February 22, 2024
• Study Completion: February 22, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Locations

FI (1)